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1.02110 SAFC

Calcium hydroxide

EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 526

Synonym: Calcium hydroxide

  • CAS Number 1305-62-0

  • Linear Formula Ca(OH)2

  • Molecular Weight 74.09

  •  MDL number MFCD00010901

  •  E Number E526

  •  EC Index Number 215-137-3

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Acidulents & pH Adjusters, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
reg. compliance   FCC
product line   Emprove® Essential
potency   7340 mg/kg LD50, oral (Rat)
pH   12.6 (20 °C in H2O, saturated solution)
mp   550 °C (decomposition)
density   2.24 g/cm3 at 20 °C
bulk density   400 kg/m3
InChI   1S/Ca.2H2O/h;2*1H2/q+2;;/p-2
InChI key   AXCZMVOFGPJBDE-UHFFFAOYSA-L
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (acidimetric): 95.0 - 100.5 %
Assay (complexometric, JP): 90.0 - 101.0 %
Identity: passes test
Substances insoluble in hydrochloric acid: ≤ 0.5 %
Carbonate (as CaCO₃): ≤ 5.0 %
Carbonate (CO₃): passes test
Chloride (Cl): ≤ 0.03 %
Fluoride (F): ≤ 0.0050 %
Phosphate (PO₄): ≤ 0.08 %
Sulfate (SO₄): ≤ 0.08 %
Heavy metals (as Pb): ≤ 0.0020 %
Al (Aluminium): ≤ 0.08 %
As (Arsenic): ≤ 0.0003 %
Ba (Barium): ≤ 0.0300 %
Cd (Cadmium)*: ≤ 0.00010
Cu (Copper): ≤ 0.0025 %
Fe (Iron): ≤ 0.05 %
Mn (Manganese): ≤ 0.025 %
Ni (Nickel)*: ≤ 0.0002
Pb (Lead)*: ≤ 0.0002 %
Si (Silicon): ≤ 0.15 %
Sr (Strontium): ≤ 0.03 %
V (Vanadium)*: ≤ 0.0010
Zn (Zinc): ≤ 0.0025 %
Magnesium and alcali salts: ≤ 2.7 %
Residual solvents (ICH Q3C): excluded by production process
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph Eur, BP, JP, USP, FCC, E 526
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Symbol 
Signal word 
Danger
Hazard statements 
Target organs 
Respiratory system
WGK Germany 
WGK 1
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

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